FDA label ca65c9f2-b5b4-4ba8-96ee-ed5a0117e640

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
a3c1cd07-a6ee-44b0-9854-622d8ba2d8f8
SPL ID
ca65c9f2-b5b4-4ba8-96ee-ed5a0117e640
Version
2
Effective date
2017-03-30
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:22:24

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Ask a doctor before use if you have stomach pain nausea vomiting a sudden change in bowel habits that lasts over a period of 2 weeks ask a doctor or pharmacist before use if Ask a doctor or pharmacist before use if you are presently taking mineral oil. Stop use and ask a doctor if you need to use a laxative for more than 1 week you have no bowel movement or have rectal bleeding. These may be signs of a serious condition. if pregnant or breast-feeding If pregnant or breast-feeding, ask a health care professional before use. keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.